Sr. Director, Regulatory Strategy, Infectious Disease
Core
Lead global regulatory strategy for mRNA infectious disease vaccine programs, ensuring alignment with business objectives and securing market approval.
Role type
Sr. Director, Regulatory Strategy (Infectious Disease/Vaccines)
Builds
Global regulatory development plans and submissions for mRNA vaccine programs
Domain
Biopharma / mRNA technology / Infectious Disease
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic regulatory planning, risk and gap assessment, FDA/EU/ICH guideline expertise, CTD format mastery, regulatory authority negotiation, portfolio management, team leadership
Preferred skills
Vaccine development experience, major application delivery (NDA/BLA/MAA), cross-functional matrix collaboration
Technologies
CTD format, FDA guidelines, EU guidelines, ICH guidelines
Responsibilities
Set strategic direction for regulatory submissions, advise project teams on regulatory strategy, conduct risk assessments, establish relationships with global health agencies, negotiate with authorities, manage regulatory resources and budgets, lead a team of regulatory strategists
Seniority
Senior, hands-on IC with team leadership
